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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name prosthesis, esophagus
510(k) Number K896390
Device Name WILSON-COOK ESOPHAGEAL PROSTHESIS
Applicant
WILSON-COOK MEDICAL, INC.
4900 BETHANIA STATION RD. &
5951 GRASSY CREEK BLVD.
WINSTON-SALEM,  NC  27105
Applicant Contact RICHARD F MARSHALL
Correspondent
WILSON-COOK MEDICAL, INC.
4900 BETHANIA STATION RD. &
5951 GRASSY CREEK BLVD.
WINSTON-SALEM,  NC  27105
Correspondent Contact RICHARD F MARSHALL
Regulation Number878.3610
Classification Product Code
JCQ  
Date Received11/06/1989
Decision Date 12/27/1989
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
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